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A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

NCT06716203 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2025-02-07

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.

The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Drug: 5 mg BGM0504 Administered SC

Drug: BGM0504 Administered SC

DRUG

Drug: : 10 mg BGM0504 Administered SC

Drug: BGM0504 Administered SC

DRUG

Drug: Placebo Administered SC

Drug: Placebo Administered SC

Sponsors & Collaborators

  • BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

    collaborator INDUSTRY

  • BrightGene Bio-Medical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2025-12-29
Completion
2026-08-25
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716203 on ClinicalTrials.gov